FDA’s April approvals include slimmer label for Xpovio, two NMEs

Among its April regulatory moves, FDA approved an sNDA withdrawing the 2020 accelerated approval for Xpovio selinexor to treat diffuse large B cell lymphoma. The XPO1 inhibitor remains approved to treat multiple myeloma.

According to the FDA website, Xpovio is the first oncology accelerated approval withdrawn since 2024. Since the program’s inception, 31 cancer approvals have been withdrawn while 124 have been converted to full approval...